Палин®

General characteristics. Structure:

Active agent - pipemidovy acid trihydrate of 235,60 mg (corresponds to pipemidoyey acid of 200,00 mg).

Magnesium excipients stearate, silicon dioxide colloid, starch corn.

Structure of the case of the capsule: titanium dioxide (Е 171), dye sunset yellow (E110), gelatin.

Structure of a lid of the capsule: titanium dioxide (Е 171), dye yellow quinolinic (Е 104), dye blue patent (Е 131), dye diamond black (Е 151), dye sunset yellow (Е 110), gelatin.

Description: opaque capsules No. 1 with the case from color, white to white with a yellowish shade, and green lid.
Contents of capsules: hydroscopic powder from color, white to almost white with a yellowish shade.

Pharmacological properties:

Pharmakodiiamika. Палин® treats drugs of group of a hinolonovy row and it is applied at treatment of infections of the urinary tract caused by activators, sensitive to pipemidoyey acid. Drug has bactericidal effect on the majority of gram-negative microorganisms (Proteus vulgaris. Proteus mirabihs, Klebsiella pneumoniae. Pseudomonas aerugiknosa. Escherichia coll. Neissena spp., etc.). It is effective concerning Staphylococcus aureus. It is not active concerning anaerobe bacterias.

Pharmacokinetics. Bioavailability makes up to 60%. After intake in a dose of 400 mg the maximum concentration of drug in plasma (Cmax) - 3,5 mkg/ml - are reached in 70-80 minutes. High concentration of active ingredient are created in kidneys, urine and liquid of a prostate. Pipemidovy acid, as well as other hinolonovy connections, gets through a placenta; gets into maternal milk poorly.

Pipemidovy acid is emitted with the most part with urine in not changed look. In daily urine 50-85% of the entered drug dose are defined release of pipemidoyey acid is in direct dependence on clearance of creatinine. Time of semi-removal of drug at normal function of kidneys makes 2 h 15 min., and the general clearance of 6.3 ml/min. At patients with renal failures higher concentration of drug in a blood plasma to what healthy volunteers are noted. The elimination half-life of pipemidoyey acid from a blood plasma is a little extended and makes 5.7 - 16 hours.

Indications to use:

The acute and chronic infectious and inflammatory diseases of urinary tract caused by microorganisms, sensitive to Palinu®, including:
- pyelonephritis;
- urethritis;
- cystitis;
- prostatitis;
- prevention of infections at tool interventions in urological and gynecologic practice.

Route of administration and doses:

Inside.

The average daily dose makes 800 mg divided into two receptions i.e. 400 mg (2 capsules) each 12 hours, in the morning and in the evening before food.

At staphylococcal infections the interval between receptions should not make more than 8 hours (i.e. the dose can be increased to 2 capsules 3 times a day) averages 10 days. If necessary the course of treatment can be prolonged depending on the course of a disease. Duration of a course of treatment is defined by the attending physician.

At diseases of kidneys duration of therapy makes from 3 to 6 weeks, at prostatitis of 6-8 weeks. During therapy plentiful drink is recommended to the patient.

At a recurrence of acute infections of urinary tract at women along with peroral treatment appointment on 1 vaginal candle for the night within 7-10 days is recommended.

Features of use:

In the course of treatment it is necessary to avoid ultra-violet radiation in connection with high risk of emergence of a photosensitization.

At prolonged use of drug it is necessary to watch the general indicators of blood, to define functions of a liver and kidneys and to repeat definition of sensitivity of microflora to Palinum.

It is necessary to increase amount of the consumed liquid (under control of a diuresis). With care it is not recommended to appoint more senior to patients than 70 years (because of the increased frequency of emergence of side effects at elderly people) and the patient with a renal failure (at an oliguria and an anury). To be careful at purpose of drug to the patients having disturbance of cerebral circulation in the anamnesis (including hemorrhage in a brain, brain vasospasms), and also spasms. The patient with epilepsy to appoint, strictly following indications with observance of precautionary measures.

As well as at treatment the risk of development of superinfection exists other antibacterial agents.

At a long course of treatment development of pseudomembranous colitis is possible. False positive reaction to urine glucose when using a reactant of Benedict or solution of Fellinga can be noted. It is recommended to use enzymatic reactions with glucose oxydas.

Influence on abilities to concentration of attention

Палин® can exert negative impact on ability to concentration of attention.

Side effects:

Side effects in most cases not demanding drug withdrawals weak and passing, as a rule. More often others nausea, vomiting, diarrhea, a gastralgia are noted. As well as at reception of other antimicrobic means, during treatment emergence of resistance or superinfection is possible.

In rare instances pseudomembranous colitis with heavy diarrhea can develop. Undesirable effects of drug from a nervous system were extremely seldom fixed. Visual disturbances, a headache, excitement, a depression, confusion of consciousness, a hallucination, a tremor, spasms were noted. Very seldom there can be big convulsive attacks. Frustration of a dream and touch disturbances are possible.

It is not recommended to use this drug at children. As well as other hinolona, pipemidovy acid collects in cartilages. The phenomenon of a muscle hyper tone at newborns and children is especially mentioned.

There can be allergic reactions - a weak itch of skin, skin rashes, Stephens-Johnson's syndrome, a photosensitization. Skin reactions are reversible. There are single messages on development of anaphylactic reactions.

At patients with insufficiency glyukozo-6-fosfatdegidrogenazy hemolitic anemia can develop. There are separate messages on development of an eosinophilia. At elderly patients and patients with renal failures thrombocytopenia can develop.

Interaction with other medicines:

Pilemidovy acid causes inhibition of enzyme of cytochrome (P450). At simultaneous use with pipemidovy acid metabolism of theophylline and caffeine is slowed down. Antacids and сукральфат considerably slow down absorption of pipemidovy acid. The interval between reception of these drugs has to make not less than 2-3 hours.

Палин® can strengthen effects of warfarin, rifampicin, Cimetidinum and non-steroidal anti-inflammatory drugs at a concomitant use.

At the combined reception with aminoglycosides a synergism concerning bactericidal action is observed.

Contraindications:

Hypersensitivity to any of drug components,
the expressed renal failures (clearance of creatinine <10 ml/min.),
the expressed abnormal liver functions (including cirrhosis),
porphyria,
diseases of the central nervous system (neurologic states with the lowered convulsive threshold),
pregnancy and period of a lactation,
children's age up to 14 years.

With care: allergic reactions to hinolona in the anamnesis.

Overdose:

There are no messages on a lethal outcome or emergence of life-threatening side effects owing to drug overdose. The specific antidote does not exist. Clinical symptoms of overdose include nausea, vomiting, dizziness, a headache, confusion of consciousness, a tremor, spasms.

In case of overdose the patient has to be under observation. At emergence of side effects from a nervous system (including epileptiform spasms) appoint a symptomatic treatment (diazepam). After recent reception (less than 4 hours) it is necessary to remove drug from a GIT with a gastric lavage, further to accept absorbent carbon for absorption reduction. Removal of drug from an organism can be accelerated by means of an artificial diuresis.

Storage conditions:

To store at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity: 5 years. Not to use drug after expiry date.

Issue conditions:

According to the recipe